Events

Rappel de ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Haemonetics Corporation.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    58658
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2420-2011
  • Date de mise en oeuvre de l'événement
    2011-04-29
  • Date de publication de l'événement
    2011-06-07
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-04-21
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99797
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Apparatus, autotransfusion - Product Code CAC
  • Cause
    2 models model 1: orthopat devices with no centrifuge drain spill containment system may have potential for fluid contamination leading to potential spark or smoke may occur are recalled model 2: orthopat equipped with a spill collection drainage system updated with revised instructions for use and quick reference guide addendum.
  • Action
    The firm, Haemonetics, sent an "Urgent Field Recall" letter dated April 29, 2011 to all customers. The letter describes the product, problem and actions to be taken. This recall covers the 2 models. Model 1: OrthoPAT devices without drain ports (Serial numbers 00001 through 02279-T). All OrthoPAT devices without drain ports worldwide, will be removed from distribution and scrapped. Model 2: OrthoPAT devices with drain ports (serial numbers beginning with 02280-T and higher). All OrthoPAT devices with drain ports will remain in clinical use and will receive updated labeling. The customers were instructed to follow the enclosed directions to confirm their possession of any units of this model and arrange for their return to Stericycle; immediately cease use of devices not equipped with a spill collection drainage system ( to determine whether their OrthoPAT device is equipped with the spill collection drainage system, please refer to the attached illustrations/instructions); complete and return the IMPORTANT-CUSTOMER CONFIRMATION sheet via fax to: Stericycle at 1-866-792-5450, and RETURN the OrthoPAT devices NOT equipped with spill collection drainage system (for instructions on how to arrange return of OrthoPAT Devices, call a Stericycle Representative at 1-866-918-8736). A Haemonetics representative will be in contact with the customers facility within 14 working days to assist with the recall actions. The firm, Haemonetics, will update the OrthoPAT labeling. The labeling will have specific instructions to permanently deploy the centrifuge spill collection bag at all times. Device cleaning instructions in the event of a blood spill are also clarified and include specific instructions to unplug the device from the AC outlet in the event of a fluid spill on the device. If a device does experience a fluid spill, new instructions direct the user to return the device to Haemonetics for evaluation and repair. Operator Manuals will be replaced with a new revisi

Device

ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION
  • Modèle / numéro de série
    Model 1: No Spill Collection System Serial numbers 00001 through 02279-T Model 2: Serial numbers beginning with 02280-T
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and countries including: Austria, Australia, Belgium, Switzerland, Canada, China, Czech Republic, Germany, Spain, Finland, France, Great Britain, Greece, Guatemala, Ireland, Israel, India, Italy, Japan, Lithuania, Luxembourg, Latvia, Monaco, Netherlands, Norway, Panama, Poland, Puerto Rico, Russian Federation, Saudi Arabia, Singapore, Slovak Republic, EI Salvador, Turkey and Taiwan.,
  • Description du dispositif
    Haemonetics OrthoPAT -Orthopedic Perioperative Autotransfusion System || US Only: 1050-110-ENG || Outside US: || 1050-110-ENG, I050-240-XXX (generic), 1050-240-ENG, 1050-240-SPN, 1050-240-ITL, 1050-240GER, || 1050-240-DUT, 1050-240-FRN, 1050-240-CZE, 1050-IIO-JPN. || Provides perioperative autotransfusion ( salvaging and reinfusing red blood cells (RBC's) from blood shed from patients undergoing orthopedic surgery. The portable system is used in operating rooms to recycle blood lost during surgery and in the recovery room to recycle blood lost after surgery. It can be transported to the patient floor for postoperative salvage.
  • Manufacturer
    Haemonetics Corporation

Manufacturer

Haemonetics Corporation
  • Adresse du fabricant
    Haemonetics Corporation, 400 Wood Rd, Braintree MA 02184-2412
  • Société-mère du fabricant (2017)
    Haemonetics Corporation
  • Source
    USFDA